CDSCO License for Intraluminal artery stripper

Introduction to Intraluminal Artery Stripper and Regulatory Importance

An intraluminal artery stripper is a specialized cardiovascular medical device designed to perform endarterectomy, a critical procedure for removing plaque deposits from arteriosclerotic arteries. Given its invasive use and potential impact on patient safety, obtaining the correct regulatory approvals from the Central Drugs Standard Control Organization (CDSCO) is essential before marketing this device in India. Proper licensing ensures compliance with Indian medical device regulations, aligns with quality and safety standards, and enables manufacturers and importers to access the growing Indian healthcare market confidently.

CDSCO Regulatory Framework for Intraluminal Artery Stripper

As per the CDSCO's medical device regulatory framework, an intraluminal artery stripper falls under the cardiovascular category and is classified as a Class B device, reflecting a moderate risk profile. The applicable notification for this device is 29/Misc./03/2020-DC (159), dated 26.7.2021. Manufacturers and importers must comply with the Medical Device Rules (MDR) 2017 and subsequent amendments for product registration, testing, and licensing.

Risk Classification and License Requirements for Class B Devices

Class B devices like the intraluminal artery stripper require a manufacturing license under the MD5 license scheme, granted by the State Licensing Authority. This classification implies moderate risk and mandates adherence to quality management systems, device testing, and audit compliance. For importers, an MD15 import license granted by the Central Licensing Authority is mandatory.

You can verify device classification details on our Medical Device Classification guide.

Manufacturing License Process (MD5) for Intraluminal Artery Stripper

The MD5 license process is comprehensive, typically spanning 3 to 4 months. Here's a stepwise overview:

1. Apply for Test License (Form MD13): Initial step requiring 1.5 to 2 months. This license allows sample testing of the device.

2. Product Testing: Conducted at CDSCO-approved laboratories. For your device, tests will focus on biocompatibility, sterility, and functional efficacy. Refer to the Testing Laboratories list to select an approved lab.

3. Document Preparation: Assemble required documents, including the Device Master File and Plant Master File.

4. Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An on-site audit ensures compliance with MDR requirements. Check the list of notified bodies for approved auditors.

6. Query Resolution: Address any concerns raised by the licensing authority or notified body promptly.

7. License Grant (Form MD5): Upon successful audit and clearance, the manufacturing license is issued.

Manufacturing License Documents Required for Class B Device

For the intraluminal artery stripper, the following documents are essential:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Comprehensive details on design, manufacturing, and performance. Our Device Master File guide offers valuable insights.
• Plant Master File (PMF): Documentation of manufacturing environment and processes. Learn more with our Plant Master File guide.
• Essential Principles Checklist confirming compliance with MDR
• Risk Management File demonstrating hazard identification and mitigation strategies. Visit our Risk Management resource for practical implementation.
• Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 compliant

Import License Process (MD15) for Intraluminal Artery Stripper

Importers must secure an MD15 license from the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

1. Document Compilation: Prepare required certifications and licenses.

2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any clarifications requested by CDSCO.

4. License Issuance (Form MD15): Upon satisfactory review, the import license is granted.

Import License Documents Required

Importers must provide:

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international approval
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Incorporation Proof

Timeline and Processing Duration

Government Fees and Costs

For the Class B intraluminal artery stripper:

• MD5 License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 Import License:

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs may include testing fees at approved labs and notified body audit charges.

Common Challenges and Solutions

Challenge: Delays in test report generation due to backlogs at government labs.

Solution: Plan testing well in advance and consider multiple approved labs to avoid bottlenecks.

Challenge: Incomplete documentation causing audit non-compliance.

Solution: Utilize detailed checklists and expert review to ensure document completeness, especially DMF and PMF.

Challenge: Misclassification of device risk class leading to incorrect license application.

Solution: Refer to official device classification resources and consult with regulatory experts to confirm risk class.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide end-to-end regulatory support for intraluminal artery strippers. From gap analysis, documentation preparation, audit facilitation, to query resolution, our expert team ensures a seamless licensing journey.

Explore our specialized guides for further reading:

• MD5 License Guide
• Import License Guide

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm that your intraluminal artery stripper is Class B.

2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.

3. Select Testing Laboratory: Choose a CDSCO-approved lab to conduct required tests.

4. Prepare Complete Documentation: Develop DMF, PMF, Risk Management files, and QMS documents.

5. Schedule Notified Body Audit: Coordinate audit timelines early to align with license application.

6. Submit Manufacturing License Application (Form MD3): After successful testing, file your application online.

7. Respond to Queries Promptly: Maintain open communication with CDSCO authorities.

By following these actionable steps and leveraging expert support, manufacturers and importers can confidently navigate the regulatory landscape to bring the intraluminal artery stripper to the Indian market efficiently and compliantly.